Recall Z-0025-2024 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson Infusion Therapy Systems Inc.
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
| Date | Oct 3, 2023 (initiated Aug 29, 2023) |
| Status | Open, Classified |
| Reason | There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed. |
| Root cause | Process change control |
| Action | On August 29, 2023, Becton Dickinson issued an "Urgent Medical Device Recall" notification via. FedEx. Becton Dickinson asked consignees to take the following actions: 1. Immediately review your inventory for Catalog Number 386862, Lot number 2238464. Destroy all unused product subject to the recall following your institution's process for destruction. 2. For indwelling catheters, no further action is needed. 3. If a defective product was used on a patient and the used needle was disposed of without the clinician suffering a needlestick injury, no further action is necessary to further pro |
| Quantity | 98,000 units |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220584 | BD Cathena Safety IV Catheter Becton Dickinson Infusion Therapy Systems, Inc., Mar 31, 2022 |